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Bifix Temp 1056

by VOCO GmbH

Ref 1056

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K143212

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Overview

Bifix Temp, a dual-curing, composite-based temporary luting material, is designed for professional dental use. It offers a stable and durable bonding solution for temporary restorations in various clinical situations.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E2210238000000000EG Basic UDI-DI E22110561UDI-DIDate30 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE22110561 UDI-DI Date22 Jan 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK143212 Date1 May 2015IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++E2210238000000000EG registered 30 Mar 2026 Active
  • FDA 510(k) K143212 decided 1 May 2015 Active
  • FDA GUDID UDI-DI E22110561 listed 22 Jan 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K143212
  2. Listed FDA GUDID E22110561
  3. Registered EUDAMED ++E2210238000000000EG

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Bifix Temp
Generic name
Dental composite resin
Model / Ref / Catalog
1056
Primary DI / UDI-DI
E22110561
Basic UDI-DI
++E2210238000000000EG
510(k) Number
FDA product code
EMA
EMDN code
Q0101010203 Temporary dental cements
GMDN term
Dental composite resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3275
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under TEMPORARY DENTAL CEMENTS.

Other devices from VOCO GmbH

See all devices from VOCO GmbH →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)